返回 Agenda
Session Chair(s)
Karl-Heinz Loebel
Director, Principle Consultant Regulatory Operations
PharmaLex GmbH, Germany
Speaker(s)
Electronic Submission of Information on Medicines in the Context of the New Pharmacovigilance Legislation in the EU: Current status and next steps
Sebastian Knieps
Lionpharm Regulatory Consulting GmbH, Germany
Managing Director
XEVMPD and IDMP: Current Challenges and Future Chances, Lessons learned from industry perspective, Impact of XEVMPD and IDMP on RIMS: A holistic approach, IDMP standards as a chance for effective and efficient regulatory data management
Timm Pauli
PharmaLex , United States
Head of Regulatory Operations
EVMPD/XEVPRM from SMEs’ perspectives, EVWEB – challenges, limitations and opportunities, overall long-term effects and expectations
Karl-Heinz Loebel
PharmaLex GmbH, Germany
Director, Principle Consultant Regulatory Operations